Endovascular Treatment of Peripheral Artery Disease.

Duomed1 site in 1 country200 target enrollmentMay 2, 2018

ConditionsPeripheral Arterial Disease Iliac Artery Disease Femoropopliteal Occlusive Disease Below-the-knee Obstruction

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Peripheral Arterial Disease
Sponsor: Duomed
Enrollment: 200
Locations: 1
Primary Endpoint: Binary restenosis
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this observational study is to evaluate the performance and safety of endovascular treatment with stenting (Optimed Sinus Superflex 635 or Qualimed Pontos-pp) or balloon angioplasty (Cardionovum Legflow or Optimed Nylotrack .035 + .018) according to current practice. The goal of the study will be achieved by assessing binary restenosis with duplex ultrasound, peri- and postoperative complications, technical success, target lesion revascularization, amputation and clinical outcome.

Registry

clinicaltrials.gov

Start Date

May 2, 2018

End Date

December 1, 2021

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Duomed

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient must sign the informed consent form prior to the index-procedure.
•Patient is older than 18 years.
•Patient is compliant with the requested follow-up visits at week 6 and month 12 and the treatment regime.
•Patient suffers from mild to intermittent claudication (Rutherford 1-3) or critical limb ischemia (Rutherford 4-5).
•Target lesion is an occlusion or diameter stenosis is ≥50% by visual estimate.
•Target lesion is located in the common and external iliac artery, in the common and superficial femoral artery, popliteal artery and/or the below-the-knee (BTK) arteries (anterior tibial artery, posterior tibial artery or peroneal artery).

Exclusion Criteria

•Patients with Rutherford 0 and
•Patient is pregnant.
•Patients with estimated Glomerular filtration rate (eGFR) \< 30 mL/min/1.73m
•Patient has an acute thrombus or aneurysm in the target arteries.
•Patient has a life expectancy of \<12 months.
•Patient has a target lesion that cannot be crossed with a guidewire.
•Patient suffers from acute limb ischemia defined as any sudden decrease in limb perfusion causing a potential threat to limb viability.
•Patient has scheduled elective non-vascular procedures within 3 months after index-procedure. Vascular procedures are allowed within 3 months after the index-procedure if it is guaranteed that acetylic salicylic acid and clopidogrel intake is not interrupted.
•Contraindication for anti-thrombotic therapy (coagulopathy, ...).
•Patient has a known intolerance to anti-thrombotic medication or contrast agents.